MAUDE Adverse Event Report: VAPOTHERM PRECISION FLOW; HUMIDIFIER, RESPIRATORY GAS

Device Problems Failure to Power Up (1476); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 12/23/2016

Event Type  Injury  

Event Description

The respiratory therapist reports that the vapotherm machine "just shut off".

• Brand Name: PRECISION FLOW
• Type of Device: HUMIDIFIER, RESPIRATORY GAS
• Manufacturer (Section D): VAPOTHERM; exeter NH 03833
• MDR Report Key: 6225131
• MDR Text Key: 64033582
• Report Number: MW5067060
• Device Sequence Number: 0
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR